MAUDE Adverse Event Report: ETHICON INC. PRLNE BLU 30IN 1 D/A XLH; SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE

Model Number	8190G
Medical Device Problem Codes	Break (1069); Defective Component (2292)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/23/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The following information was requested, but unavailable: was the whole suture uneven or just a segment? just a segment.Was the suture diameter other than expected? no further information is available.Was the suture used on the patient? no further information is available.Could you please provide the lot number? no further information is available.Procedure name? no further information is available.Attempts have been made to retrieve the device.To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.
Event or Problem Description
It was reported that a patient underwent an unknown procedure on (b)(6) 2021 and suture was used.During the procedure, it was found that there had been a part where the suture was likely to break.There was a possibility that the thickness of the suture was uneven.No adverse patient consequences were reported.Additional information was requested.
Additional Manufacturer Narrative
(b)(4).Date sent to the fda: 5/25/2021.This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon inc, or its employees that the report constitutes an admission that the product, ethicon inc or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Additional h3 investigation summary: the product was returned for evaluation.Visual inspection evaluation was conducted on the returned device.The product code is double armed.Visual analysis of the returned sample determined that one opened sample of product code 8190 was received for evaluation, the needles were cut from suture and the swage and attachment area of two were noted to be as expected, the suture was observed with damaged on the surface and the ends were cut appears to be by use of the surgical instrument.The product code 8190 contains absorbable suture and as the sample was received open, the time of exposure of suture to the environment could not be determined and no functional test can be performed due to sample condition.The condition of the sample received indicates improper handling of the device.The manufacturing records couldn't be reviewed as the batch number is unknown.It should be noted that as part of our quality process, each batch is randomly inspected and functionally tested during manufacturing to ensure the device meets the required specifications prior to shipment.

• Brand Name: PRLNE BLU 30IN 1 D/A XLH
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• MDR Report Key: 11679425
• Report Number: 2210968-2021-03453
• Device Sequence Number: 3049577
• Product Code: GAW
• UDI-Device Identifier: 10705031013209
• UDI-Public: 10705031013209
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K133356
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 8190G
• Device Catalogue Number: 8190G
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/03/2021
• Initial Date Received by Manufacturer: 03/24/2021
• Supplement Date Received by Manufacturer: 05/03/2021; 05/03/2021
• Initial Report FDA Received Date: 04/16/2021
• Supplement Report FDA Received Date: 05/25/2021; 05/26/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1